Clinical study on the bioequivalence of two tablet formulations of flurbiprofen

Flurbiprofen (CAS 5104-49-4) is a member of phenylalkanoic acid derivative group of nonsteroid anti-inflammatory drugs. It exhibits anti-inflammatory, analgesic and antipyretic activities. Two different tablets containing flurbiprofen (FLU) were investigated in 24 healthy volunteers to prove the bioequivalence between both treatments after single oral dose administrations. Fluroben (R) 100 mg tablet and 100 mg tablet of the originator product were used as test and reference preparation respectively. The study was performed open label, randomized, two period cross-over design with 15 days wash out period. Blood samples were taken up to 24 hours for pharmacokinetic profiling. The plasma concentrations of flurbiprofen were determined with validated HPLC-UV method. Maximum plasma concentration (C-max) of FLU 19 143.65 ng/ml and 19 164.22 ng/ml were found for test and reference formulation respectively. Areas under the plasma concentration time curve AUC(0-infinity) of 118 501.4 ng.h/ml and 111 339.8 ng.h/ml were calculated test and reference formulation respectively. Primary target parameters AUC(0-infinity), and C-max, both of them were tested parametrically by analysis of variance (ANOVA); 90% confidence intervals were between 100.5%-111.18% for AUC(0-infinity). and 87.6%-115.0% for C-max. All these values were within the acceptance range (80%-125%) for bioequivalence studies

Serum zinc levels in children of 0–24 months diagnosed with pneumonia admitted to our clinic

Aim: We have planned to study the relationship between zinc (Zn) plasma levels, as well as pneumonia criteria, and zinc in healthy children younger than 2 years of age compared to pediatric patients diagnosed with pneumonia and admitted to a hospital. Materials and methods: The study enrolled 25 patients of 0-24 months referring to our hospital's pediatric clinic, who were then diagnosed with bronchopneumonia based on the World Health Organization diagnostic criteria and admitted to suckling children clinic due to inability to receive out-patient treatment, and 10 healthy children of the same age group, whose physical examinations revealed no pathological findings. Results: There was no difference between the groups in terms of age and gender distribution (p> 0.05). The control group included in the study showed a significantly higher mean duration of breast milk intake compared to the patient groups (p<0.001). WBC values obtained from the patient group was significantly higher than that of the control group (p<0.001). Zn and iron (Fe) values as determined in the control group enrolled in the study were significantly higher compared to the patient group (p<0.01). Mean total protein in the control group was found to be significantly higher versus that of the patient groups (p<0.05). With regard to the r values of correlation coefficients of the subjects enrolled in the study, a slightly positive correlation was observed between Zn levels and iron levels (r=0.457). Conclusion: It was concluded that infections, particularly pneumonia, which present a serious issue both in our country and developing countries, may be developed more commonly among children with zinc deficiency